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Completed

NCT Number: NCT01575340

Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer

The purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil modifies inflammatory markers in individuals with colorectal cancer in chemotherapy

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammation Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Pesquisas Oncológicas - CEPON

Florianópolis, Santa Catatina, 88034-000, Brazil

About this study

The study will recruit patients with newly diagnosed colorectal cancer and that has not yet undergone any chemotherapy treatment. Individuals that meet the inclusion criteria are randomized by means of a computer program on two study groups: 1) supplemented Experimental: receive 2g/day supplementation encapsulated fish oil for 9 weeks. 2) No intervention - control: not receive supplementation of fish oil or placebo. Will be assessed the effects of supplementation on the standard profile of cytokine production, nutritional status, and proportion of incorporation of these fatty acids in blood cells (mononuclear and red blood cells).

Blood samples are collected before the start of first chemotherapy and nine weeks later. Supplementation in the experimental group also will start on the first day of chemotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 19 years
  • Histopathological diagnosis of colorectal cancer
  • Beginning of chemotherapy in the target institution
  • Agree to participate in the study [signature of IC]

Exclusion criteria

  • Age <19 years
  • Being in palliative care
  • Inability to oral intake
  • Allergic to the fish and fish products
  • Owning with hyperlipidemia requiring drug treatment
  • Consumption prior to the study of fish oil or supplements containing omega-3 PUFA
  • Being in medical treatment with some nonsteroidal anti-inflammatory
  • Have some kind of infection

Treatment and study plan

fish oil encapsuled

Dietary Supplement

2 g/d (4 capsules of 500 mg)for 9 weeks

Other names: omega-3 encapsuled

Primary outcomes

  1. change in inflammatory markers

    Time frame: two months

    will be evaluated cytokines IL-1 beta, IL-10, IL-17A and TNF alpha, and acute phase proteins CRP and Albumin, in baseline that corresponds to the day that the patient will begin chemotherapy and the final moment, which corresponds to 9 weeks counting from the baseline in both groups (supplemented and non-supplemented)

Secondary outcomes

  1. change in body composition

    Time frame: two months

    will estimate the percentage of body fat in each patient through the use of skinfold thickness at baseline and end to study in both groups

  2. change in nutritional status

    Time frame: two months

    will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI

  3. Changes in plasma lipid profile

    Time frame: two months

    will evaluate the proportion of incorporation of omega-3 fatty acids in plasma

  4. assessing the risk of inflammatory and nutritional complications

    Time frame: two months

    Will be calculated the ratio PCR / albumin, as proposed by Correa et al., 2002, using the cutoff points proposed by the same author for the classification of high, medium, decreased or no risk

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Catarina

Other

Collaborators

  • Centro de Pesquisas Oncológicas de Florianópolis
  • Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina

Registry information

Official study title

Markers of the Inflammatory Response (IL-1β, IL-10, IL-17A and TNF-α) in Patients With Colorectal Cancer in Chemotherapy Supplemented With Fish Oil

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2012
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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